rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 3/14/2019 |
| Start Date: | April 1, 2019 |
| End Date: | July 1, 2019 |
| Contact: | Kyle J. O'Laughlin, MS |
| Email: | olaughk@ccf.org |
| Phone: | 216-445-6728 |
Contralaterally Controlled FES Combined With Brain Stimulation for Severe Upper Limb Hemiplegia
This study is a necessary and important step in the development of a new therapy for upper
limb functional recovery in patients with severe motor impairment. It is the first clinical
trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or
rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher
motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive
results obtained in our short-term pilot study can be made to last longer and produce
functional benefits in severe patients with the application of brain stimulation in
combination with long-term rehabilitation therapy. Rehabilitation therapy administered is
called contralaterally controlled functional electrical stimulation (CCFES). Determining
whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in
functional abilities in severe patients is necessary for acceptance by the clinical community
and to move this technology toward commercialization and widespread dissemination. The
proposed study will determine whether the combination of rTMS facilitating the cHMC with
CCFES produces greater improvements in upper extremity function in severe participants who
are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged
hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the
combination of sham rTMS and CCFES. The secondary purposes are to define which patients
benefit most from the treatments, which may inform future device and treatment development
and clinical translation, and to explore what distinct effects the three treatments have on
the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls
severe stroke patients.
limb functional recovery in patients with severe motor impairment. It is the first clinical
trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or
rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher
motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive
results obtained in our short-term pilot study can be made to last longer and produce
functional benefits in severe patients with the application of brain stimulation in
combination with long-term rehabilitation therapy. Rehabilitation therapy administered is
called contralaterally controlled functional electrical stimulation (CCFES). Determining
whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in
functional abilities in severe patients is necessary for acceptance by the clinical community
and to move this technology toward commercialization and widespread dissemination. The
proposed study will determine whether the combination of rTMS facilitating the cHMC with
CCFES produces greater improvements in upper extremity function in severe participants who
are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged
hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the
combination of sham rTMS and CCFES. The secondary purposes are to define which patients
benefit most from the treatments, which may inform future device and treatment development
and clinical translation, and to explore what distinct effects the three treatments have on
the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls
severe stroke patients.
Overall Study Design Summary: We propose a 5-yr RCT in which 72 stroke patients who are >6
months post-stroke are randomized to 12 wks of one of 3 treatments: (1) CCFES + cHMC
facilitation, (2) CCFES + iM1 facilitation, (3) CCFES + Sham rTMS. The treatment dose will be
the same for all groups: 10 sessions per week (7.5 hrs) of self-administered CCFES-assisted
hand opening exercises performed at home plus 2 sessions per week (2.5 hrs) consisting of
group-specific rTMS and CCFES-mediated functional task practice performed in the laboratory.
Upper limb impairment, activity limitation, and patient-reported disability will be assessed
at 0 (baseline), 6, 12 (end of treatment), 24, and 36 wks. Neurophysiology (IHI and
excitability of uncrossed output) will be assessed at 0 (baseline), 12 (end of treatment),
and 36 wks, on a separate day from functional motor outcomes assessment. MRI assessment of
stroke lesion and location, and DTI assessment of corticospinal damage will be performed at
baseline.
months post-stroke are randomized to 12 wks of one of 3 treatments: (1) CCFES + cHMC
facilitation, (2) CCFES + iM1 facilitation, (3) CCFES + Sham rTMS. The treatment dose will be
the same for all groups: 10 sessions per week (7.5 hrs) of self-administered CCFES-assisted
hand opening exercises performed at home plus 2 sessions per week (2.5 hrs) consisting of
group-specific rTMS and CCFES-mediated functional task practice performed in the laboratory.
Upper limb impairment, activity limitation, and patient-reported disability will be assessed
at 0 (baseline), 6, 12 (end of treatment), 24, and 36 wks. Neurophysiology (IHI and
excitability of uncrossed output) will be assessed at 0 (baseline), 12 (end of treatment),
and 36 wks, on a separate day from functional motor outcomes assessment. MRI assessment of
stroke lesion and location, and DTI assessment of corticospinal damage will be performed at
baseline.
Inclusion Criteria:
- age 21 to 80 years old at time of randomization
- greater than 6 months since a first clinical cortical or subcortical, ischemic or
hemorrhagic stroke
- severe upper limb hemiparesis defined as less than 10° active wrist extension or less
than 10° active thumb abduction/extension or less than 10° active extension in at
least two additional digits (i.e., will not meet minimum CIMT criteria)
- ability to follow 3-stage commands and can remember 2 items from a list of 3 items
after 3 minutes
- adequate active movement of shoulder and elbow to position the paretic hand on one's
lap for performance of functional task practice and CCFES-assisted hand opening
exercises
- skin intact on hemiparetic arm
- surface electrical stimulation of the paretic finger and thumb extensors produces
functional hand opening without pain
- able to hear and respond to cues from stimulator
- completed occupational therapy at least 3 months prior to enrollment (no concomitant
OT)
- full volitional hand opening/closing of the non-paretic hand
- ability to follow instructions for putting on and operating the CCFES stimulator or a
caregiver available to provide assistance
Exclusion Criteria:
- metal implant in the head
- history of seizures as an adult
- history of alcohol or substance abuse less than 10yrs prior to enrollment
- intake of anticonvulsants or anti-depressants contraindicated with TMS
- cardiac pacemaker or other programmable implant
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